Cytolityc T Lymphocytes for Cytomegalovirus infection (post-allogeneic hematopoietic stem cell transplantation)

Inclusion criteria

• {"criterion_text":"- Adult patients (over 18 years of age), whether or not diagnosed with hematologic malignancy, who have received an allogeneic HSCT hematopoietic progenitor transplant from HLA-identical family donors\n- b. The donor will be screened to determine suitability according to the HSCT hematopoietic progenitor donor evaluation criteria\n- C. The donor has to also sign a written informed consent prior to inclusion\n- Non-candidates to receive Letermovir\n- Source of HSC progenitors: peripheral blood or bone marrow\n- Patients whose donor is CMV seropositive\n- Negative pregnancy test in women\n- Written informed consent signed by the patient or legal representative\n- Partial recovery of the hematopoietic implant (absolute neutrophil count >0.5 x10^9 cells/L for at least 3 consecutive post-HSCT determinations)\n- Specific inclusion criteria for donors:\n- a. Donors will be selected if they meet HLA identity criteria and are CMV seropositive"}

Exclusion criteria

• {"criterion_text":"- MUST NOT MEET ANY OF THE ESTABLISHED CRITERIA for the prescription of LETERMOVIR in CMV seropositive adult recipients of an allogeneic HSCT:\n- ECOG > or = 3\n- Organ toxicity greater than grade 3 according to CTCAE Version 5.0\n- Uncontrolled infection, defined by fever and/or hemodynamic instability and/or unresolved infectious focus.\n- Persistent fever (>38ºC) in the 3 days prior to the infusion\n- Relapse or active and uncontrolled progression of the malignant disease\n- CMV viral reactivation prior to the day of infusion (21 post-HSCT) requiring anti-viral treatment (more than 200 copies of CMV by PCR in 2 determinations or more than 1000 in 1 determination).\n- Previous therapy with Letermovir\n- Specific exclusion criteria for donors:\n- a. Active infection at the time of lymphoapheresis\n- Related donor with at least one mismatch at one of the HLA locus (HLA-A, -B or -DR)\n- Haploidentical donor\n- Unrelated donor with at least one mismatch at one of the four HLA gene loci (HLA-A, -B, -C and -DRB1)\n- Use of cord blood\n- Use of graft with ex vivo T-lymphocyte depletion\n- GvHD grade 2 or higher requiring the use of systemic corticosteroids (doses ≥1mg/kg/day of prednisone or equivalent doses of other corticosteroids\n- AND MUST NOT MEET ANY OF THE CRITERIA BELOW to participate in the study:\n- Treatment at the time of cell infusion with corticosteroid doses greater than 0.5mg/kg/day of prednisone or equivalents"}

Primary endpoints

• {"endpoint_text":"- efficacy is the incidence of CMV infection AT DAY 100 POST-TPH (measured as viral load >200 copies in 2 determinations or >1000 in 1 determination [PCRq]).","definition_or_measurement_approach":"Incidence of CMV infection at day 100 post-transplant (TPH), measured by PCR quantitative viral load: >200 copies in 2 determinations or >1000 in 1 determination."}

Secondary endpoints

• {"endpoint_text":"- Assess the need for CMV treatment\n- To evaluate the incidence of CMV disease\n- to assess the presence of allogeneic CMV-specific memory T lymphocytes","definition_or_measurement_approach":"Assess the need for CMV treatment: not further specified. To evaluate incidence of CMV disease: not further specified. To assess presence of allogeneic CMV-specific memory T lymphocytes: exploratory measurements (persistence) by flow cytometry on the day of cell infusion (±7 days), at 1 month and 2 months after hematopoietic progenitor infusion (as per secondary objectives)."}

Spain

Latest Decision Or Authorization Date

02-01-2026

Processing Time Days

350

Number Of Sites

3

Number Of Participants

32

Primary sponsor

Full Name

Instituto De Investigacion Marques De Valdecilla

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain